Job Details

Job Title: Facilities Sr. Validation Engineer

Location: San Angelo, TX

Job Type: W2 Contract – 1 Year (Potential for Extension)

Position Summary:

The Facilities Sr. Validation Engineer is responsible for leading the planning, execution, and oversight of infrastructure projects and validation of equipment and processes in a regulated manufacturing environment. This role emphasizes project management, validation compliance, and facility operations to ensure optimal performance, safety, and compliance with regulatory standards.

Key Responsibilities:

Validation & Compliance:

• Execute validation protocols including IQ, OQ, and PQ for equipment and processes.
• Ensure strict compliance with FDA, ISO, and internal SOPs.
• Maintain accurate documentation for validation and system modifications.
• Support audits by interfacing with Quality and Regulatory teams.

Project Management & Planning:

• Develop business cases and present proposals to leadership.
• Lead capital projects including scheduling, tracking, and execution.
• Oversee vendor bidding, negotiations, and procurement activities.
• Maintain cost control, budget tracking, and accurate cost estimations.
• Supervise contractor performance against quality and compliance benchmarks.

Facilities & Maintenance Oversight:

• Manage facility upgrades and construction initiatives.
• Maintain critical systems (HVAC, cleanroom, sterilization, nitrogen, compressed air, purified water, heaters, fire systems).
• Conduct safety inspections and ensure adherence to EHS regulations.
• Lead facility reliability and stabilization improvements.

Collaboration & Communication:

• Coordinate across departments and external stakeholders.
• Participate in validation design reviews and issue resolution meetings.
• Mentor contractors and teams in safety and compliance.
• Provide technical support during planned outages or holidays.

Qualifications:

Education:

• Bachelor's degree in Engineering or a related technical discipline.

Experience:

• 5+ years in a regulated manufacturing environment with a focus on facilities engineering and validation.
• Strong knowledge of facility systems: HVAC, compressed air, cleanrooms, water systems, etc.
• Proven experience in validation methods: Risk Assessment, FAT, CSV, IQ, OQ, PQ.
• Familiar with capital project methodologies and lifecycle execution.

Technical Skills:

• Proficient in Microsoft Office (Excel, PowerPoint, Project, Word), AutoCAD.
• Strong Excel and PowerPoint proficiency highly desirable.
• Experience with PMO tools, KPI tracking, and reporting.

Soft Skills:

• Strong analytical and problem-solving skills.
• Effective verbal and written communication in English.
• Proven team leadership and cross-functional collaboration.

Certifications (Preferred):

• PMP, Lean Six Sigma Black Belt, FPX, or similar certifications.